BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PLI GVF INS 4 8MM

    MDR report key: 7124975 · Received December 18, 2017

    Report

    Report Number
    1818910-2017-51866
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 24, 2017
    Report Date
    November 24, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JWH
    UDI-DI
    10603295062608
    PMA / PMN Number
    K040166
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE FOLLOWING IMPLANTS WERE REMOVED BY SURGEON DURING REVISION SURGERY DUE TO POLYETHYLENE WEAR AND TIBIAL AND FEMORAL LOOSENING SIZE 4 TIBIA. 866024, LOT 2063687; SIZE 4 LEFT CR FEMUR 960004, LOT UNREADABLE; SIZE 4 8MM PLI INSERT 158104008?, LOT 2048223 ORIGINAL SURGERY APPROXIMATELY 11 YEARS AGO. NO REPORT IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904321 SIGMA PLI GVF INS 4 8MM TIBIAL INSERT JWH DEPUY INTERNATIONAL LTD - 8010379 2048223 10603295062608

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention